VIV Podcast

What’s trending and timely in life sciences? Updates on Global systems and regulatory guidances

On this episode, we welcome back Karen Ginsbury, President & CEO of PCI Pharmaceutical Consulting Israel for updates on new with global systems and regulatory guidelines.

What’s new in Quality Management System

  • For Virtual companies, what are their responsibilities in terms of quality systems?
  • What’s the new EU guidance around vendors and responsibility?
  • What will the impact be of new Draft PIC/S recommendations on how to demonstrate the effectiveness of a Pharmaceutical Quality System?
  • What are the differences in protocols for QRM systems in digitally enabled and fully automated labs?
  • What’s happening with Annex 1?

More information on the topics discussed can be found at:

  1. ISO 18091:2019 Quality management systems — Guidelines for the application of ISO 9001 in local government
  2. Validation Week 2020
  3. FDA Information on PQS
  4. ICH Q10 Quality Management
  5. IT and Computerized Systems Conference
  6. ICH guideline Q10 on pharmaceutical quality system
  7. ICH guideline Q9 on quality risk management


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